Parsabiv FDA Approval History

FDA Approved: Yes (First approved February 7, 2017)
Brand name: Parsabiv
Generic name: etelcalcetide
Dosage form: Injection
Company: Amgen Inc.
Treatment for: Secondary Hyperparathyroidism

Parsabiv (etelcalcetide) is a calcium-sensing receptor agonist indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

Development timeline for Parsabiv

Date	Article
Feb 8, 2017	Approval FDA Approves Amgen's Parsabiv (etelcalcetide) for Secondary Hyperparathyroidism in Adult Patients on Hemodialysis
Aug 24, 2016	Amgen Provides Update on Status of Parsabiv (Etelcalcetide) NDA Submitted to the U.S. FDA
Nov 6, 2015	FDA Accepts Amgen's New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide
Aug 25, 2015	Amgen Submits New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416)

Further information

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

Parsabiv FDA Approval History

Development timeline for Parsabiv

See also

Further information